Celgene halts testing of new application for cancer drug

By ,
July 18, 2013 at 2:26 PM

Celegene Corp. will halt late-stage trials of its blood cancer drug Revlimid, which the company is seeking to broaden for more uses, after observing higher deaths among leukemia patients taking the drug compared with another treatment.

The Summit-based biotech was conducting a study to evaluate safety of Revlimid on patients aged 65 and older with B-cell chronic lymphocytic leukemia.

Celgene said there were 34 deaths out of 210 patients, compared with 18 deaths out of 211 patients using chlorambucil, an older treatment. The Food and Drug Administration thus placed the study on hold July 12, Celgene said. No specific reason for this imbalance has been identified, the company said.

Most of the patients had ailments such as diabetes and congestive heart failure, which Celgene said precluded more aggressive chemotherapy treatment.

The company said all other Celgene-sponsored trials on chronic lymphocytic leukemia are proceeding accordingly.

Remlivid is Celgene’s biggest growth driver, bringing in $3.8 billion in sales in 2012 and about $1 billion in this year’s first quarter. The drug is approved to treat blood-related cancers such as multiple myeloma in the United States, Europe and elsewhere. It is also approved for severe anemia and mantle cell lymphoma in the United States.

Celgene stock declined on the news. Shares fell 2.7 percent, or $3.65, to $132.96 in afternoon trading on the Nasdaq.

The Summit-based biotech was conducting a study to evaluate safety of Revlimid on patients aged 65 and older with B-cell chronic lymphocytic leukemia.

Celgene said there were 34 deaths out of 210 patients, compared with 18 deaths out of 211 patients using chlorambucil, an older treatment. The Food and Drug Administration thus placed the study on hold July 12, Celgene said. No specific reason for this imbalance has been identified, the company said.

Most of the patients had ailments such as diabetes and congestive heart failure, which

Celgene said precluded more aggressive chemotherapy treatment.

The company said all other Celgene-sponsored trials on chronic lymphocytic leukemia are proceeding accordingly.

Remlivid is Celgene’s biggest growth driver, bringing in $3.8 billion in sales in 2012 and about $1 billion in this year’s first quarter. The drug is approved to treat blood-related cancers such as multiple myeloma in the United States, Europe and elsewhere. It is also approved for severe anemia and mantle cell lymphoma in the United States.

Celgene stock declined on the news. Shares fell 2.7 percent, or $3.65, to $132.96 in afternoon trading on the Nasdaq.